Department of Clinical Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.
Eur Rev Med Pharmacol Sci. 2023 May;27(10):4583-4593. doi: 10.26355/eurrev_202305_32465.
The study aimed to determine the impact of using sildenafil citrate as an adjuvant with clomiphene citrate (CC) in the treatment of women with unexplained infertility.
130 women with unexplained infertility were enrolled in a prospective randomized study. After dividing into two groups, all patients received CC 50 mg-BD from the 2nd to the 7th day of the cycle. Oral sildenafil citrate 20 mg was given BD to the study group from the end of menstruation till ovulation. A transvaginal ultrasound was carried out for all patients to assess ovulation, number of follicles, and endometrial thickness (ET). The beta-hCG blood test was used to determine pregnancy two weeks after ovulation followed by an ultrasound to confirm viability. Adverse effects were recorded and miscarriage, ectopic, and multi-fetal pregnancy were followed up for twelve weeks.
Median ET in the study group was 8 mm compared to 7 mm in the control group (p<0.01). The number of pregnancies increased in the study group but with no significant difference. The median ET was greater in the study group with an infertility duration of less than 2 years. Headache was the most significant adverse effect in the study group (9.2% vs. 1.5%, p=0.052).
Adding sildenafil citrate to CC is a good choice for overcoming the antiestrogenic action of CC and improving ET in women with unexplained infertility, especially in those with less than 2 years of infertility.
本研究旨在探讨枸橼酸西地那非作为枸橼酸氯米酚(CC)辅助用药在治疗不明原因不孕妇女中的作用。
本前瞻性随机研究纳入了 130 例不明原因不孕妇女。将患者分为两组后,所有患者均在周期第 2 至 7 天接受 CC 50mg,bid 治疗。研究组从月经结束至排卵期间,每日接受 20mg 枸橼酸西地那非口服治疗。所有患者均接受阴道超声检查以评估排卵、卵泡数量和子宫内膜厚度(ET)。排卵后两周进行β-hCG 血检以确定妊娠,随后进行超声检查以确认胚胎存活。记录不良反应,随访 12 周内的流产、异位妊娠和多胎妊娠。
研究组的 ET 中位数为 8mm,而对照组为 7mm(p<0.01)。研究组的妊娠率有所增加,但无显著差异。在不孕时间<2 年的患者中,研究组的 ET 中位数更大。研究组最常见的不良反应是头痛(9.2% vs. 1.5%,p=0.052)。
在 CC 中添加枸橼酸西地那非是克服 CC 的抗雌激素作用并改善不明原因不孕妇女 ET 的一种选择,尤其是在不孕时间<2 年的患者中。